KR102668076B1 - A water purification apparatus and a method for controlling at least one fluid property in a water purification apparatus - Google Patents

Abstract

The present disclosure relates to water purification devices and corresponding methods that include a reverse osmosis device (RO device) that produces a flow of purified water. The proposed method includes detecting at least one fluid characteristic of the purified water in the purified water path and, based on the at least one detected fluid characteristic, adjusting the flow rate of water in the recirculation path to meet one or more predetermined criteria of the purified water in the purified water path. Includes adjusting steps. The disclosure also relates to computer programs and computer program products implementing the methods.

Description

Water purification device and method for controlling at least one fluid property in the water purification device {A WATER PURIFICATION APPARATUS AND A METHOD FOR CONTROLLING AT LEAST ONE FLUID PROPERTY IN A WATER PURIFICATION APPARATUS}

The present disclosure relates to a water purification apparatus and a corresponding method for controlling at least one fluid property in the water purification apparatus. The disclosure also relates to computer programs and computer program products implementing the methods.

For the treatment of patients suffering from acute or chronic renal failure, dialysis therapy is employed. The three general categories of dialysis therapy are hemodialysis (HD), peritoneal dialysis (PD), and continuous renal replacement therapy (CRRT).

In hemodialysis, the patient's blood is washed by passage through an artificial kidney in an extracorporeal membrane system integrated into the dialysis machine. Hematologic therapy is performed extracorporeally through an exchanger with a semipermeable membrane (dialysis machine) in which the patient's blood circulates on one side of the membrane and dialysis fluid containing the major electrolytes of the blood at concentrations close to those in the blood of a healthy subject circulates on the other side. It involves circulation. Moreover, a pressure difference is created between the two compartments of the dialyzer bounded by the semi-permeable membrane, such that a fraction of the plasma fluid passes by ultrafiltration through the membrane into the compartment containing the dialysis fluid.

CRRT is used as an alternative therapy for patients who are too critically ill or unstable for standard hemodialysis. It is similar to hemodialysis and uses a semi-permeable membrane for diffusion and to some extent convection. However, this is a slower form of blood treatment than hemodialysis and may last from a few hours to several days.

In peritoneal dialysis, dialysis fluid is injected into the patient's peritoneal cavity. This cavity is lined by highly vascularized peritoneum. Metabolites are removed from the patient's blood by diffusion across the peritoneum and into the dialysis fluid. Excess fluid, i.e. water, is also removed by osmosis induced by the hypertonic dialysis fluid. Through these two processes, diffusion and osmotic ultrafiltration, appropriate amounts of solute metabolites and fluid must be removed to maintain the patient's body fluid volume and composition within appropriate limits.

Continuous ambulatory peritoneal dialysis (“CAPD”), automated peritoneal dialysis (“APD”), including tidal flow APD, and continuous flow peritoneal dialysis (“CFPD”). There are various types of peritoneal dialysis therapy, including ).

CAPD is a passive dialysis treatment. The patient manually connects the implanted catheter to a drain, allowing pulmonary dialysis fluid to drain from the peritoneal cavity. The patient then connects the catheter to a bag of fresh dialysis fluid, injecting the new dialysis fluid into the patient through the catheter. The patient disconnects the catheter from the fresh dialysis fluid bag and allows the dialysis fluid to reside in the peritoneal cavity, where transfer of waste, toxins, and excess water occurs.

Automated peritoneal dialysis (“APD”) is similar to CAPD in that dialysis treatment includes drain, fill, and retention cycles. However, APD machines typically perform the cycle automatically while the patient sleeps. APD machines eliminate the need for patients to manually perform treatment cycles and transport supplies during the day. The APD machine is fluidly connected to the implanted catheter, a source or bag of fresh dialysis fluid, and a fluid drain. The APD machine pumps fresh dialysis fluid from a dialysis fluid source through a catheter into the patient's peritoneal cavity, allowing the dialysis fluid to remain within the cavity and allow the transfer of waste products, toxins, and excess water to occur. The APD machine pumps lung dialysate from the peritoneal cavity, through a catheter, and into a drain. As with manual processes, multiple drain, fill and retention cycles occur during APD. “Final filling” often occurs at the end of CAPD and APD, which remains in the patient's peritoneal cavity until the next treatment.

Both CAPD and APD are batch type systems that deliver waste dialysis fluid to a drain. The tidal system is a modified batch system. With the tide, instead of removing all fluid from the patient over a longer period of time, a portion of the fluid is removed and replaced after smaller increments of time.

Continuous flow or CFPD systems clean or recycle spent dialysate without discarding it. CFPD systems are typically more complex than batch systems.

CAPD, APD (including algae) and CFPD systems can employ pumping cassettes. Pumping cassettes typically include a flexible membrane that is mechanically moved to push and pull dialysis fluid out of and into the cassette, respectively.

In one form of peritoneal dialysis, an automatic circulator is used to infuse and drain dialysis fluid. This form of treatment can also be performed automatically at night while the patient sleeps. The circulator calculates net fluid removal by measuring the amount of fluid injected and the amount removed. The treatment sequence typically begins with an initial drainage cycle to empty the lung dialysate from the peritoneal cavity. The circulator then performs a series of fill, hold, and drain cycles, typically ending with a fill cycle.

Peritoneal dialysis generally requires large amounts of dialysis fluid. Typically, at each application or exchange, a given patient will infuse 2 to 3 liters of dialysis fluid into the peritoneal cavity. The dialysis fluid is allowed to reside for approximately 1 to 3 hours, at which time it is drained and replaced with fresh dialysis fluid. Typically, four such exchanges are performed each day. Accordingly, approximately 8 to 20 liters of dialysis fluid are required for each patient each day, 7 days a week, 365 days a year.

Dialysis fluids for use in the aforementioned treatments are traditionally supplied in sealed container bags, ready for use. For example, peritoneal dialysis is typically performed using bags with three different concentrations of dextrose. The bags are being delivered to patients' homes in 1 liter to 6 liter bags with different dextrose concentrations. Normal daily consumption is approximately 8 to 20 liters of PD dialysis fluid. Fluids are supplied in sterile bags up to 6 liters in size. These sterile bags are packaged in boxes and delivered, for example, monthly, for use in the patient's home. Boxes of fluids can be cumbersome and heavy for PD patients to handle, and take up significant space in a room in the patient's home. Bags and boxes also generate a relatively large amount of waste that is discarded weekly or monthly.

In view of the above, several problems become apparent. Delivery and storage of the enormous amounts of fluid required are space-consuming. Additionally, the use of multiple pre-filled bags generates waste material in the form of empty containers and packaging.

Therefore, there is a need for a subsystem for total peritoneal dialysis, for example a system for generating dialysis solution in a PD machine.

PD dialysis fluid is delivered directly into the patient's peritoneal cavity. Accordingly, PD fluids need to have a level of sterilization suitable for introduction into the patient's peritoneum. PD dialysis fluid is thus typically premixed and sterilized prior to delivery to the point of use, typically the patient's home.

Additionally, in hemodialysis and CRRT, systems for producing dialysis solutions at the point of use, for example in hemodialysis machines or CRRT machines, are therefore required.

A complete system for hemodialysis, PD or CRRT, in some embodiments, includes three main components: a dialysis machine, a purifier, and a disposable set that operates with both the dialysis machine and the purifier. A dialysis machine is for example a PD circulator, hemodialysis machine or CRRT machine. Dialysis machines prepare and concentrate dialysis fluid from purified water from a water purifier.

A water purifier produces purified water at the point of use, for example from tap water.

Under certain circumstances, it is desirable to deliver a flow rate of product water of a certain size. For example, it makes it possible to deliver a certain amount of purified water in a timely manner or to overcome the pressure drop caused by a filter located downstream of the water purification device. However, the hardware of water purification devices and filters may deteriorate over time. For example, sterilizing grade filters may become clogged by bacteria and endotoxins and possibly other substances. This may affect the product water flow rate from the water purification device. Therefore, throughput for constant pressure will decrease over time. Accordingly, the amount of purified water produced by the water purification device may be uncertain. Accordingly, one object of the present disclosure is to control the characteristics of the product water flow, for example to maintain a constant (or fairly constant) flow rate or pressure. Another objective is to maintain the operating points (eg pressure, temperature or flow rate) of the components within the water purification device within certain intervals.

These and other objects are achieved at least in part by the apparatus and method according to the independent claims and by the embodiments of the dependent claims.

According to a first aspect, the present disclosure relates to a water purification device for producing purified water. The water purification device includes a reverse osmosis (RO) device, an RO pump, a recirculation path, a purified water path, a purified water path, a control device, at least one detector, and a control unit. - A reverse osmosis (RO) device is configured to produce a flow of purified water, the RO device includes a feed inlet configured to receive feed water and a purified water outlet, and an RO pump is configured to pump the feed water to the feed inlet. Moreover, the recirculation path is configured to recirculate a portion of the purified water flow from a first point downstream of the RO device to a second point upstream of the RO device, and the purified water path is configured to convey the purified water from the purified water outlet to the product water port. The purified water path includes a product water path arranged downstream of the recirculation path to convey purified water to the product water port. The control unit is configured to control the control device to adjust the flow rate of purified water in the recirculation path based on the fluid properties detected by the at least one detector. At least one detector is configured to detect product fluid characteristics of the product water in the product water path. The control unit is further configured to control the control device to control the product fluid properties of the product water in the product water path to meet one or more predetermined product water criteria, based on the product fluid properties detected by the at least one detector. . The at least one detector includes a flow sensor, and the product fluid characteristic detected by the flow sensor is the flow rate of product water in the product water path. Additionally, the one or more predetermined product quantity criteria include that the flow rate of the product quantity within the product quantity path corresponds to the predetermined flow rate.

Accordingly, one or multiple fluid properties within the purified water path of the water purification device may be controlled. More specifically, one or more product fluid properties of the product water of the dialysis machine may be controlled such that desirable product fluid properties are maintained throughout production and also during startup and shutdown, for example. Here, the desired flow rate of product water may be maintained over time.

According to some embodiments, the at least one detector includes a pressure sensor, wherein the product fluid characteristic detected by the pressure sensor is the pressure of the fluid in the product water path, and the one or more predetermined product water criteria is the product fluid quantity in the product water path. maintaining the pressure of the product water below a predetermined upper pressure level and/or the pressure of the product water in the product water path corresponding to the predetermined pressure. Accordingly, the pressure of the product water in the product water path may be controlled to remain within a desirable range for optimal operation. Accordingly, damage or deterioration of components due to too high pressure in the product water path may be avoided.

According to some embodiments, the at least one filter is configured to filter product water flowing through the product water path, and the predetermined upper pressure level is the pressure of the at least one filter or any other component arranged within the product water path. Corresponds to the tolerance level.

As water is pumped through the filter, bacteria and endotoxins, and possibly other substances, may reduce the permeability of the filter arranged in relation to the product water path. This means that for a given pressure, throughput will decrease over time. By using the proposed technique, the pressure of the product water in the product water path can be increased to the maximum permissible level to compensate for this behavior.

According to some embodiments, the control unit is configured to activate an alarm function in response to a change in at least one product fluid characteristic detected by the at least one detector. Therefore, if a suspected error is detected, the operator or patient may be warned.

According to some embodiments, the control unit is configured to control the control device to obtain a predetermined flow rate through the product water port for a predetermined period of time to produce a predetermined amount of water. Accordingly, the requested amount of product may be produced by the dialysis machine. The quantities requested are typically between 0.5 and 400 liters, for example 1, 2, 5, 10, 20, 50, 70, 90, 150, 200 or 300 liters.

According to some embodiments, a water purification device includes a heater configured to heat product water flowing within a product water path. Accordingly, product water having the temperature requested by the dialysis machine may be produced. Heaters may also be used to control the temperature of the RO membrane of the RO device.

According to some embodiments, the water purification device includes a temperature sensor arranged to measure the temperature of water in the purified water path downstream of the heater. According to these embodiments, the control unit is configured to control the control device to control the temperature of water flowing through the RO membrane of the RO device, based on the temperature detected by the temperature sensor. Accordingly, the temperature of the RO membrane may remain fairly constant, which may be desirable for operation.

According to some embodiments, a water purification device includes a tank arranged to receive water from an external water source and provide water to a feed inlet.

According to some embodiments, the water purification device includes a polisher device arranged downstream of the recirculation circuit in the purified water path. Polisher devices include, for example, Electrodeionization (EDI) devices.

According to some embodiments, the water purification device includes a permeate path configured to convey purified water from a purified water outlet of the RO device to an inlet of the polisher device.

According to some embodiments, the product water path is configured to convey purified water from the outlet of the polisher device to the product water port.

According to a second aspect, the present disclosure relates to a corresponding method for controlling at least one fluid property in a water purification device producing purified water. The water purification device includes a reverse osmosis device (RO device) that generates a purified water flow, and a recirculation path configured to recirculate a portion of the purified water flow from a point downstream of the RO device to a point upstream of the RO device. The method includes detecting at least one product fluid characteristic of the purified water in the purified water path, the product water path comprising detecting at least one product fluid characteristic of the product water in the product water path, wherein the product water path is downstream of the recirculation path. a detecting step, wherein arranged, and based on the at least one detected product fluid characteristic, adjusting the flow rate of water in the recirculation path to meet one or more predetermined product count criteria of the product water in the product water path. , based on at least one detected fluid characteristic, adjusting the flow rate of water in the recirculation path to meet one or more predetermined criteria of purified water in the purified water path. The at least one product fluid characteristic includes a flow rate of product water in the product water path, and the one or more predetermined product water criteria includes a flow rate of water in the product water path corresponding to the predetermined flow rate.

Accordingly, as discussed above, product fluid properties may be controlled to meet specific criteria prescribed by, for example, the manufacturer or user. Therefore, water production may be more effective and dialysis treatment may be safer. The method also makes it possible to make smaller, faster changes in product water flow rate than when only adjusting the pumping frequency used to supply water to the RO device.

According to some embodiments, the method includes estimating the amount of purified water produced during the production time based on the duration of the production time and a corresponding flow rate of purified water detected during the production time. The possibility of controlling the pressure makes it possible to avoid high pressures in the product water path, which could lead to destruction in the worst case.

According to some embodiments, the method includes triggering a predetermined action when the quantity reaches a predefined production volume. For example, an alert signal or action (e.g., a message is sent to a dialysis machine) may be triggered when the requested volume is generated.

According to some embodiments, the at least one product fluid characteristic comprises a pressure within the product water path, and the one or more predetermined product water criteria comprises the pressure of the product water within the product water path remaining below a predetermined upper pressure level. do.

According to some embodiments, the method includes measuring the temperature of water in the purified water path downstream of a heater arranged in the purified water path. According to this embodiment, the regulating step then includes, based on the temperature detected by the temperature sensor, adjusting the flow rate of water in the recirculation path such that the temperature of the water flowing through the RO membrane of the RO device meets a predetermined temperature criterion. Includes.

Thereby, the temperature range of the water passing into the RO membrane will be less dependent on the temperature of the inlet water and the ambient temperature, since a return flow of heated purified water may be used to increase the temperature of the water in the tank. Therefore, the filtration behavior of the membrane will be more stable.

According to some embodiments, the method includes performing the detecting step and the regulating step continuously while the water purification device produces purified water.

According to some embodiments, the method includes activating an alert function in response to a change in at least one detected product fluid characteristic. Therefore, the proposed method according to these embodiments also allows the water purifier to detect sudden changes in pressure, such as breakthrough of a filter, which leads to a lower pressure drop and thereby a lower pressure in the product water path and This means increased flow rate. Alternatively, a leak between the purifier and filter will also cause a pressure drop, which will cause the alarm to clear.

According to some embodiments, the predetermined upper pressure level is the pressure tolerance of at least one filter arranged to filter product water downstream of the product water path or any other component arranged within or within a predetermined distance from the product water path. Corresponds to the level.

According to some embodiments, the controlling step includes controlling the fluid properties of the product water to obtain a predetermined flow rate for a predetermined time to produce a predetermined amount of water. Moreover, the purifier may continue to deliver the requested amount to the dialysis machine even if communication to the dialysis machine is lost. The predetermined amount is typically 0.5 to 400 liters.

According to some embodiments, the method includes controlling the temperature of product water flowing within the product water path.

According to some embodiments, the polisher device is arranged downstream of the recirculation circuit in the purified water flow, and the product water path is arranged to convey product water from the outlet of the polisher device to the product water port.

According to a third aspect, the present disclosure relates to a computer program comprising instructions that, when the program is executed by a computer, cause the computer to perform the methods described above and below.

According to a fourth aspect, the present disclosure relates to a computer-readable medium comprising instructions that, when executed by a computer, cause the computer to perform the methods described above and below.

Embodiments of the invention are described in more detail with reference to the accompanying drawings, which illustrate examples of embodiments of the invention:
1 is a front elevation view of one embodiment of a PD dialysis system with point-of-care dialysis fluid generation using purified water from a water purification device.
Figure 2 is an elevation view of one embodiment of a disposable set for use with the system shown in Figure 1;
Figure 3 is a schematic diagram of some functional units of a water purification device.
FIG. 4A shows a first example embodiment of a water purification device 300 including an RO device 301 .
Figure 4b shows the function of the control unit of the water purification device 300.
Figure 5 shows a flow chart of the method for use in a dialysis machine.
Figure 6 shows an exemplary water purification device in more detail.

For example, when using a water purification device for point-of-care treatment, it may be desirable to be able to control the flow rate of purified water, i.e., product water. If the flow rate of product water is constant or at least known, it is possible to predict the amount of water produced during a specific production time.

Generally, it is desirable to produce the desired quantity of product as quickly as possible. However, if the product water flow rate is too high, the pressure of the water within the water purification device may be too high, which may cause damage to the fluid system within the water purification device and other hardware or associated with the water purification device. Moreover, if the product water flow rate or pressure is too high, for example, filters within the dedicated line set arranged to provide product water to the dialysis machine may break, creating a risk of bacteria and endotoxins reaching the patient. .

Accordingly, the proposed technology proposes a method for controlling the product water flow rate from a water purification device based on one or more product fluid properties or parameters, such as the product water flow rate, pressure, or temperature within the product water path. Control is implemented, for example, using electrically controlled proportional valves in the recirculation path of the water purification device. Electrically controllable valves can also be used to control other fluid properties of purified water, such as pressure or temperature.

In order to better understand the proposed technology, a water purification device in which the proposed technology may be implemented is described below as a part included in a peritoneal dialysis system. However, the proposed technology produces purified water for other types of dialysis systems, e.g., hemodialysis or CRRT systems, for use in the manufacture of dialysis fluid to be used in hemodialysis or CRRT treatment performed by the system at the field or point of use. It may also be implemented in a water purification device used to do so.

Referring now to the drawings, and particularly to Figure 1, a peritoneal dialysis system with point-of-use dialysis fluid production is illustrated by system 10a. System 10a includes a circulator 20 and a water purification device 300. Suitable circulators for circulator 20 include, for example, Amia® or HomeChoice® circulators sold by Baxter International Inc., which circulators are updated to perform and use point-of-use dialysis fluid produced in accordance with system 10a. I understand that advanced programming is necessary. For this purpose, the circulator 20 comprises a control unit 22 with at least one processor and at least one memory. Control unit 22 further includes a wired or wireless transceiver for transmitting information to and receiving information from water purification device 300 . Water purification device 300 also includes a control unit 112 having at least one processor and at least one memory. Control unit 112 further includes a wired or wireless transceiver for transmitting and receiving information to and from control unit 22 of circulator 20 . Wired communication may also take place via an Ethernet connection, for example. Wireless communication is via any of the following protocols: Bluetooth ^™ , WiFi ^™ , Zigbee®, Z-Wave®, wireless Universal Serial Bus (“USB”), or infrared protocols, or via any other suitable wireless communication technology. It could be. When the program is executed by the control unit 22, the control unit 22 causes the control unit 22 and the water purification device to execute any one or more of the methods and programs according to any one of the embodiments disclosed herein. Includes a computer program containing instructions to perform. The instructions may be stored in a computer-readable medium such as a portable memory device, such as a USB memory, a portable computer, or the like, and loaded into the control unit 22.

The circulator 20 prepares fresh dialysis fluid at the point of use, pumps the freshly prepared dialysis fluid into the patient P, allows the dialysis fluid to remain within the patient P, and then pumps the used dialysis fluid to a drain. It includes a housing (24) that holds the equipment programmed through a control unit (22). In Figure 1, water purification device 300 includes a first drain path 384 leading to a drain 339, which may be a housing drain or a drain container. Equipment programmed through control unit 22 to prepare fresh dialysis solution at the point of use may include, but is not limited to: (i) one or more positive pressure reservoirs, (ii) one or more negative pressure reservoirs, (iii) one or more A compressor and a vacuum pump, each under the control of control unit 22, to provide positive and negative pressures to be stored in the positive and negative pressure reservoirs, or a single pump producing both positive and negative pressures under the control of control unit 22. , (iv) a plurality of pneumatic valve chambers for transmitting positive pressure and negative pressure to the plurality of fluid valve chambers, (v) a plurality of pneumatic pump chambers for transmitting positive pressure and negative pressure to the plurality of fluid pump chambers, (vi) a plurality of pneumatic valve chambers for transmitting positive pressure and negative pressure to the plurality of fluid pump chambers. a plurality of electrically actuated on/off solenoid pneumatic valves under the control of a control unit (22) located between the pneumatic valve chamber and the plurality of fluid valve chambers, (vii) located between the plurality of pneumatic pump chambers and the plurality of fluid pump chambers; a plurality of electrically actuated variable orifice pneumatic valves under the control of a control unit 22, (viii) a heater under the control of a control unit 22 for heating the dialysis fluid when mixed in one embodiment, and (viii) an alarm, and In other situations it may also include equipment for a pneumatic pumping system comprising an occluder 26 under the control of a control unit 22 for occluding patient and drain lines.

In one embodiment, the plurality of pneumatic valve chambers and the plurality of pneumatic pump chambers are located on the front face or front surface of the housing 24 of the circulator 20. The heater is located within the housing 24 and, in some embodiments, includes a heating coil in contact with a heating fan located on the top of the housing 24 beneath a heating cover (not shown in Figure 1).

Circulator 20 of FIG. 1 also includes a user interface 30. In an embodiment, control unit 22 includes a video controller, which may have its own processing and memory for interacting with the primary control processing and memory of control unit 22. User interface 30 includes a video monitor 32, which operates as a touch screen overlay disposed on video monitor 32 for inputting commands to control unit 22 via user interface 30. You may. User interface 30 may also include one or more electromechanical input devices, such as membrane switches or other buttons.

Water purification device 300 of FIG. 1 also includes a user interface 120. Control unit 112 of water purification device 300 may then include a video controller, which may have its own processing and memory for interacting with the primary control processing and memory of control unit 112. there is. User interface 120 includes a video monitor 122, which may also operate as a touch screen overlay disposed on video monitor 122 for inputting commands to user control unit 112. User interface 120 may also include one or more electromechanical input devices, such as membrane switches or other buttons. The control unit 112 may further include an audio controller for playing a sound file, such as an alarm or warning sound, in one or more speakers 124 of the water purification device 300.

With further reference to Figure 2, a disposable set 40 is shown. Disposable set 40 is also shown in FIG. 1 and is coupled with circulator 20 to move fluid within disposable set 40 and mix dialysis fluid, for example, as described herein. In the example shown, the disposable set 40 includes a disposable cassette 42, which may include a planar rigid plastic part covered on one or both sides by a flexible membrane. The membrane pressed against the housing 24 of the circulator 20 forms a pumping and valving membrane. 2 shows a fluid pump chamber 44 in which a disposable cassette 42 operates in conjunction with a pneumatic pump chamber located in the housing 24 of the circulator 20 and a pneumatic valve chamber located in the housing 24 of the circulator 20. It is shown comprising a fluid valve chamber 46 operating in conjunction with.

1 and 2 illustrate that disposable set 40 includes a patient line 50 extending from a patient line port of cassette 42 and terminating at a patient line connector 52. 1 shows a patient line connector 52 connected to a patient transfer set 54 which is then connected to an indwelling catheter positioned in the peritoneal cavity of patient P. Disposable set 40 includes a drain line 56 extending from a drain line port of cassette 42 and terminating at a drain line connector 58. 1 shows a drain line connector 58 removably connected to a drain port 118 of the water purification device 300 to receive used dialysis fluid from the circulator 20.

1 and 2 show that the disposable set 40 includes a heater/mix line 60 extending from a heater/mix line port in the cassette 42 and terminating in a heater/mix bag 62 described in more detail below. It also shows what to do. Disposable set 40 includes an upstream water line segment 64a extending to the water inlet of water accumulator 66. Downstream water line segment 64b extends from water outlet 66b of water accumulator 66 to cassette 42. In the example shown, upstream water line segment 64a begins at water line connector 68 and is located upstream from water accumulator 66. Figure 1 shows that the water line connector 68 is removably connected to the product water port 128 of the water purifier 110.

The water purification device 300 outputs purified water and water (“WFPD”) suitable for, for example, peritoneal dialysis. WFPD is water suitable for preparing dialysis fluid for delivery to the peritoneal cavity of the patient (P). WFPD is, for example, water for dialysis or water for injection.

In one embodiment, a sterilization grade filter 70a for sterilization is disposed upstream from a sterilization grade filter 70b for downstream sterilization. Filters 70a, 70b may be disposed in water line segment 64a upstream of water accumulator 66. The sterilizing grade filters 70a, 70b may be pass-through filters without rejection lines. The pore size of the sterile filter may be less than 1 micron, for example 0.1 or 0.2 micron. Suitable sterilizing grade filters 70a, 70b may be, for example, Pall IV-5 or GVS Speedflow filters, or may be filters provided by the assignee of the present invention. In an alternative embodiment, only one or more than two sterilizing grade filters are disposed within the water line segment 64a upstream of the water accumulator 66. One or more sterilizing grade filters may be arranged proximate the water accumulator 66, making it easier for the disposable set 40 to be folded. In another alternative embodiment, there is no sterilizing grade filter within the water line segment 64a. The sterilization grade filter for sterilization may be replaced by, for example, one or more ultrafiltration filters located in the product water path of the water purification device 300.

Figure 2 also shows that a last bag or sample line 72 may be provided extending from the last bag or sample port of the cassette 42. The last bag or sample line 72 terminates at a connector 74, which may be connected to a mating connector of a premixed last fill bag of dialysis fluid or to a sample bag or other sample collection vessel. The last bag or sample line 72 and connector 74 may alternatively be used for a third type of concentrate if desired.

1 and 2 show that the disposable set 40 includes a first concentrate line 76 extending from the first concentrate port of the cassette 42 and terminating at a first cassette concentrate connector 80a. I'm doing it. A second concentrate line 78 extends from the second concentrate port of cassette 42 and terminates at a second cassette concentrate connector 82a.

1 shows a first concentrate container 84a being pumped from a container 84a through a container line 86 to a first container concentrate connector 80b that mates with a first cassette concentrate connector 80a. , for example, is shown holding a glucose concentrate. The second concentrate container 84b has a second, e.g. For holding the buffer concentrate.

To begin treatment, the patient (P) typically loads the cassette 42 into the circulator and places, in a random or specified order, (i) the heater/mixing bag 62 onto the circulator 20, and (ii) Connecting the upstream water line segment 64a to the product water port 128 of the water purification device 300, (iii) connecting the drain line 56 to the drain port 118 of the water purification device 300, (iv) ) Connect the first cassette concentrate connector 80a to the first container concentrate connector 80b, and (v) connect the second cassette concentrate connector 82a to the second container concentrate connector 82b. At this point, patient connector 52 is still capped. Once the new dialysis fluid is prepared and verified, the patient line 50 is primed with the new dialysis fluid, and then the patient P may connect the patient line connector 52 to the delivery set 54 for treatment. Each of the above steps may appear graphically on video monitor 32 and/or be presented through audio instructions from speaker 34.

The water purification device 300 will now be described in more detail.

3 shows a schematic diagram of the functionality of a water purification device 300 including a pretreatment module 160, a reverse osmosis (RO) module 170, and a post-treatment module 180. The water purification device 300 includes an inlet port 399 for supplying water from a water source 398, for example, tap water, to the water purification device 300 for purification of water. Influent from the water source is supplied into the pretreatment module 160 through inlet port 399.

Pre-processing module

Pretreatment module 160 treats the influent water with a particle filter and a bed of activated carbon.

The particle filter is arranged to remove particles such as clay, silt and silicon from the influent water. The particle filter is arranged to block micrometer-sized particles, and optionally also larger endotoxin molecules, from the influent.

The bed of activated carbon is arranged to remove chlorine and chlorine-bearing compositions from the influent water and absorb toxic substances and pesticides. In an exemplary embodiment, the bed of activated carbon is arranged to remove one or more of hypochlorite, chloramine, and chlorine. In another exemplary embodiment, the bed of activated carbon is also arranged to reduce organic compounds (TOC total organic carbon), including pesticides, in the influent.

In some embodiments, the particle filter and bed of activated carbon are integrated into one single consumable part. Consumable parts are exchanged at predefined intervals, depending, for example, on the influent water quality. The quality of the influent water is inspected and determined by a qualified person prior to first use of the water purification device 300, for example in the field.

Optionally, pretreatment module 160 includes an ion exchange device for protection of downstream devices, such as reverse osmosis (RO) membranes and polishers.

The pretreatment module 160 thus filters the influent water and delivers the pretreated water to the RO module 170 located downstream.

RO module

The RO module 170 removes impurities such as microorganisms, pyrogens, and ionic substances from the pretreated water by the influence of reverse osmosis from the filtered water. The pretreated water is pressurized by a pump and forced through the RO membrane to overcome osmotic pressure. RO membranes are for example semi-permeable membranes. Thereby, the stream of pretreated water, referred to as feed water, is split into a reject stream of water and a stream of permeate water. In an example embodiment, rejected numbers may pass through one or both of the first rejection path and the second rejection path. The first reject path recirculates the reject water back to the feed water path of the RO pump for refeeding back into the RO device. The recycled reject water increases the feed flow to the RO device to obtain sufficient flow past the reject side of the RO membrane to minimize scaling and fouling of the RO membrane. The second rejection path leads to the rejection water being drained. This ensures that the concentration level on the reject side is adequate and low enough to achieve the required permeate fluid concentration. If the feed water has a low solute content, a portion of the drain flow may also be directed back to the inlet side of the RO membrane, thereby increasing the water efficiency of the water purification device 300.

The RO module 170 thus treats the pretreated water and delivers the permeate to a post-treatment module 180 located downstream.

Post-processing module

The post-treatment module 180 polishes the permeate water to further remove ions from the permeate water. The permeate is polished using a polisher device, such as an electrical deionization (EDI) device or a mixed bed filter device.

EDI devices use electrical deionization to remove ions from the permeate such as aluminum, lead, cadmium, chromium, sodium and/or potassium that have penetrated the RO membrane. EDI devices use electricity, ion exchange membranes, and resins to deionize permeate water and separate dissolved ions, or impurities, from the permeate water. The EDI device produces polished water that is polished to a higher purity level than the purity level of the permeate water by the EDI device. The EDI device has an antibacterial effect on product water, and above all, it can reduce the amount of bacteria and endotoxin in the water due to the electric field of the EDI device. In one embodiment, the EDI device has a capacity to produce between 70 and 210 ml/min of product water. The capacity of the EDI device therefore sets limits on the flow rate of product water.

A mixed bed filter device includes a column or vessel with a mixed bed ion exchange material.

The polished water, also referred to herein as product water, is then ready to be delivered from the product water port 128 of the water purification device 300 to the product water's point of use. The product water is suitable for dialysis, that is, water for dialysis. In one embodiment, the product water is water for injection. In an exemplary embodiment, a disposable set 40 including a water line 56 is arranged in the water purification device 300 to convey product water to the point of use. Optionally, water purification device 300 includes a drain port 118. Drain port 118, in one exemplary embodiment, connects drain line 64 for further conveyance to drain 339 of water purification device 300 via first drain path 384 within water purification device 300. It is used to receive used fluid, for example from PD patients. As a further option, the drain port 118 receives a sample of the mixed solution ready for further transport to the water purification device 300, for example to a conductivity sensor arranged in the first drain path 384. The disposable set 40 is here arranged with sterilizing filters 70a, 70b for filtering the product water from the water purification device 300 to ensure the quality of the product water as water for injection.

Accordingly, the product water collected within the accumulator bag 66 is passed through one or more sterilizing grade filters of the disposable set 40 for removal of bacteria and endotoxins, i.e., to produce sterile product water. According to one embodiment, the sterilization grade filter for sterilization is redundant.

By collecting sterile product water within accumulator bag 66, purification device 300 and circulator 20 are uncoupled in terms of pressure, such that the high pressure required to push the water through a sterilizing grade filter is released into the circulator ( 20) has no effect.

The control unit 112 of the water purification device 300 operates the water purification device 300 in different operating states, for example, 'STANDBY', 'CONNECT', 'IDLE', and 'RUN'. )' and 'MAINTENANCE'. The water purification device 300 is arranged to act upon instructions from the circulator 20.

When the water purification device 300 is not in use but is powered on, it is set to a standby state.

In the 'standby' state, the water purification device 300 waits for a 'connection' or 'maintenance' command.

The main stages of the different states are explained. Steps taken to mitigate risk, such as comparing flow sensors, testing flow paths for leaks, etc., are omitted.

Status 'Connected'

During the 'connected' state, the system tests sensors and checks EDI devices to ensure that the system is ready when a command to proceed to the 'idle' state is received. The state 'Connect' may also include flushing of certain components, for example in the preprocessing module 160.

The patient is also typically asked to take a sample of the influent water, at a sampling port located after the pretreatment module 160. What was found in these samples was that levels of chlorine, including hypochlorite, chloramines and chlorine, were below tolerance levels.

When all steps in the 'Connected' state have been performed, the system is ready for use.

Status 'children'

In this state, the water purification device 300 awaits a return fluid conductivity measurement (when freshly prepared dialysis fluid is tested) or a request for a new supply of product from the circulator 20.

In this state, the water purification device 300 may prepare itself to supply product water. The water purification device 300 then begins producing product water, but instead of delivering product water from product port 128, the produced product water is recycled to tank 350 until the product water achieves a stable conductivity level. , the RO device is operating at the desired operating point of the RO device 301.

The water purification device 300 occasionally recirculates the water path to minimize the start time of the water generation phase.

The state 'idle' may also include flushing of certain components, for example in the preprocessing module 160.

Status 'Driving'

In the 'running' state, the water purification device 300 supplies product water (e.g., the volume requested by the circulator 20) to the disposable set accumulator bag 66.

The proposed technique will now be explained in more detail with reference to FIGS. 4A, 4B and 5.

FIG. 4A shows a water purification device 300 including an RO device 301. Note that Figure 4A is only a conceptual diagram and shows only a portion of the water purification device 300 related to the proposed technology. A more detailed description of the exemplary water purification device 300 and its operation is provided with respect to FIG. 6 .

The water purification device 300 in FIG. 4A includes an RO device 301, a tank 350, an RO pump 450, a feed water path 390, a recirculation path 375, a purified water path 371, and a control device 305a. , a temperature sensor 303, a pressure sensor 308, a flow sensor 309, a heater 302, a flow sensor 380, a product water port 128, and a control unit 112.

RO device 301 is arranged to produce a purified water flow and a rejection flow. More specifically, the RO device 301 includes an RO membrane 324, a feed inlet 301a, a purified water outlet 301b, and a reject outlet 301c. RO membrane 324 separates the feed inlet 301a and reject outlet 301c from the purified water outlet 301b. The reject flow is directed into the first reject path 385b and/or into the drain 339 of the water purification device 300. The first rejection path 385b is fluidly connected to the rejection outlet 301c and the feed water path 390.

The feed water path 390 is arranged to convey feed water to the feed inlet 301a. The feed water path 390 is fluidly connected to the feed inlet 301a.

A tank 350 is arranged in the feed water path 390 to collect water. More specifically, tank 350 is arranged to receive water from an external water source and provide water to feed inlet 301a. According to some embodiments, tank 350 is optional, which is indicated by a dashed line in Figure 4A.

The RO-pump 450 is arranged in the feed water path 390 to pump feed water to the feed inlet 301a. RO pump 450 is arranged downstream of tank 350 (if present). The RO pump 450 is configured to be controlled at a specific pump speed corresponding to a specific flow rate of the permeate flow. Because the permeability of the RO membrane 324 increases as the temperature of the feed water increases, the relationship between pump speed and flow rate depends on the temperature of the water supplied to the feed inlet 301a, and therefore the temperature of the RO membrane 324. It depends.

The product water port 128 is arranged to provide product water to, for example, a dialysis machine, for example, via a dedicated line set. A sterilizing grade filter (not shown) is located in a line set outside the water purification device 300, typically downstream of the product water port 128.

The recirculation path 375 is arranged to recirculate a portion of the purified water flow from a first point downstream of the RO device 301 to a second point upstream of the RO device 301 . More specifically, the recirculation path 375 is arranged to circulate heated purified water within the water purification device 300 from a point downstream of the RO device 301 to the feed water path 390. Purified water is recycled to tank 350 in the example of FIG. 4A and fed back to the feed inlet 301a of RO device 301. However, purified water may alternatively be recycled directly into the water line upstream of RO pump 450.

The purified water path 371 is fluidly connected to the purified water outlet 301b and the product water port 128. The purified water path 371 is configured to transport purified water from the purified water outlet 301b to the product water port 128. The purified water path 371 includes a permeate water path 371a and a product water path 371c. Product water path herein refers to the portion of purified water path 371 closest to product water port 128, where fluid properties such as pressure and flow rate are the same (or similar) as at product water port 128. .

The heater 302 is arranged to heat the product water flowing within the product water path 371c. The heater 302 is, for example, a heater arranged to heat purified water produced by the RO device 301. Moreover, in the example of FIG. 4A , purified water leaving RO device 301 also passes through flow sensor 410 and temperature sensor 303 included in permeate path 371a.

Purified water path 371 includes a polisher device 306, such as an electrical deionization (EDI) device. Alternatively, polisher device 306 is a mixed bed filter device. The polisher device 306 is arranged downstream of the recirculation circuit 374 in the purified water path 371. Accordingly, the polisher device 306 is arranged in the purified water path 371 downstream of the point where the recirculation path 375 is connected to the purified water path. The polisher device 306 is fluidly connected to the permeate water path 371a and the product water path 371c. In other words, according to some embodiments, the permeate water path 371a is arranged to convey purified water from the purified water outlet 301b of the RO device 301 to the inlet of the polisher device 306, and the product water path 371c is arranged to convey purified water from the outlet of the polisher device 306 to the product water port 128.

The present disclosure provides that fluid properties, such as pressure or flow rate of product water in product water path 371c, may be controlled by controlling the portion of the permeate flow produced by the RO device that is recycled to feed inlet 301a. It is based on insight. A control device 305a, such as an electrically controllable valve, is arranged to enable such control. In other words, the control device 305a is arranged to regulate the flow rate of purified water in the recirculation path 375. According to some embodiments, control device 305a is configured to receive control data and adjust the rate of permeate flow being recycled based on the control data. Control data may be electrical signals (analog or digital). Control device 305a is typically a flow control device, such as a proportional valve. Proportional valves are typically electrically controlled. However, mechanical proportional valves may also be used. In one embodiment, the control device 305a is a pump, for example a positive displacement pump, such as a volumetric pump or a piston pump.

As described above, the proposed technology enables control of at least one fluid property, such as flow rate or pressure, within the product water path 371c when the water purification device is operated. According to some embodiments, the proposed technology allows control of the temperature of the RO membrane 324 or other properties, such as the operating point of the RO device, for example, permeate fluid properties. To enable such control, the relevant fluid property (or properties) needs to be measured or at least somehow detected or estimated. Accordingly, the at least one detector is arranged to detect fluid properties of the purified water in the purified water path 371.

According to some embodiments, the at least one detector is arranged to detect product fluid properties of product water within product water path 371c. At least one detector may be implemented in multiple ways. According to some embodiments, the at least one detector is configured to provide product fluid property data defining at least one product fluid property. According to some embodiments, the control is based on other characteristics, such as permeate fluid properties, for example, the temperature of purified water flowing within permeate path 371a.

In Figure 4A, the at least one detector is a flow sensor 309 and a pressure sensor 308. Next, the product fluid characteristic measured by the flow sensor 309 is the flow rate of product water in the product water path 371c. The product fluid characteristic detected by pressure sensor 308 is the pressure within product water path 371c. Additionally, the temperature sensor 303 is arranged to measure the temperature of the purified water in the permeate path 371a downstream of the heater 302.

Control unit 112 typically includes one or more microprocessors 1122 and/or one or more circuits, such as application specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), etc. Includes.

Control unit 112 may also include non-transitory memory units (e.g., hard drives, flash memory, optical disks, etc.) and/or volatile storage devices (e.g., dynamic random access memory (DRAM)). It may also include at least one memory 1123 such as .

The control unit 112 communicates with other components of the water purification device 300, in particular the control device 305a and at least one detector, for example a pressure sensor 308 and/or a flow sensor 309 (e.g. , transmitting control data and receiving sensor data).

The control unit 112 is configured to perform the functions of the water purification device 300. In particular, control unit 112 is configured to implement all embodiments of the proposed techniques described herein, including the methods described in relation to FIG. 6 . To achieve this, the control unit 112 is configured to receive fluid property data from at least one detector and transmit control data to the control device 305a. More specifically, the control unit 112 is configured to adjust the flow rate of the purified water in the recirculation path 375 based on the fluid properties detected by the at least one detector, for example one of the purified water in the purified water path 371. It is configured to control the control device 305a to meet the above predetermined criteria. Fluid properties are measured, for example, by any sensor within the purified water path 371.

According to some embodiments, control unit 112 is configured to determine one or more predetermined products based on fluid properties detected by at least one detector, such as, for example, pressure sensor 308 and/or flow sensor 309. It is configured to control the control device 305a to control the product fluid properties of the product water in the product water path 371c to meet the water standard. In other words, the control unit 112 is configured to control the flow rate of water in the recirculation path 375 to meet one or more criteria, such as, for example, obtaining specific fluid properties, such as a specific pressure or flow rate within the product water flow. .

As described above, different product fluid properties may be controlled. Accordingly, the product number standard may include one or more control conditions. Some examples will now be provided. It should be understood that these examples may be used alone or in combination. In its simplest form, at least one product count criterion contains only one single condition.

In the first example, the goal of control is to achieve a constant product water flow rate. The control criterion would then be to attempt to maintain a constant product water flow rate through product water port 128. The flow rate through product water port 128 is typically the same (or at least approximately the same) as in the overall product water path 371c. Accordingly, according to some embodiments, the predetermined criterion includes that the flow rate of product water in product water path 371c corresponds to a predetermined flow rate, for example, 150 ml/min or 250 ml/min. If a constant flow rate of product water can be obtained, it is easy to estimate how long it will take to produce a specific amount of product water.

For example, the water purification device 300 may be controlled to generate product water with a specific constant product water flow over a predetermined period of time. In other words, according to some embodiments, the control circuit is configured to control the control device 305a to obtain a predetermined flow rate through the product water port 128 for a predetermined period of time to produce a predetermined amount of water. . The predetermined amount is for example between 0.5 and 400 liters. The predetermined amount may correspond to the amount needed for one or multiple dialysis treatments. For example, the purification device 300 may be controlled to produce 0.5, 1, 2, 5, 10, 20, 50, 70, 90, 150, 200, 250, 300 or 400 liters of purified water.

In a second example, the goal of control is to achieve a limited or controlled product water pressure. The pressure of the product water in the product water path 371c should typically not exceed the maximum tolerance level. The maximum tolerance level would be to ensure that hardware, such as, for example, filters within or associated with the water purification device or polisher device 306, is not damaged. In other words, according to some embodiments, the predetermined upper pressure level corresponds to a pressure tolerance level of at least one filter (e.g., a sterilizing grade filter) or any other component arranged in product water path 371c. . Accordingly, according to some embodiments, the predetermined criteria include the pressure of the product water within the product water path 371c being maintained below a predetermined upper pressure level.

Typical implementations of predetermined criteria include, for example, a predetermined flow rate of product water in product water path 371c, as long as the pressure of product water in product water path 371c remains below a predetermined upper pressure level. may include controlling the control device 305a to attempt to obtain . If the pressure reaches the predetermined upper pressure level, the control device 305a will instead control the control device to maintain the pressure at that level even if the flow rate of product water in the product water path becomes less than the predetermined flow rate.

As previously discussed, throughput for a given product water pressure will decrease over time. By controlling how much permeate is recycled within the recycle path 375, the product water pressure can be continuously increased to compensate for this behavior. In other words, according to some embodiments, the predetermined product count criterion includes the pressure of the product count within the product count path 371c corresponding to the pressure level. The pressure level within product water path 371c may correspond, for example, to expected throughput through product water port 128 and may therefore vary (typically increase) over time.

In a third example, the target of control is the permeate path 371a, for example the RO device 301 (considered to be at least partially included in the permeate path 371a) or the polisher device 306. ) or a hardware component within the polisher water path 371b (FIG. 6) is to maintain a specific point of action of one or more of the hardware components of the water purification device 300. The point of action is, for example, a certain pressure, a certain flow rate or a certain temperature. The action point criterion is then typically formulated to maintain the action point within a certain interval.

For example, the flow rate or pressure of water in permeate path 371a immediately downstream of RO device 306 is measured (or estimated) using flow sensor 410. In principle, any detector in the permeate water path 371a or the polisher water path 371b may be used.

Next, permeate fluid properties, such as pressure within the RO device (particularly transmembrane pressure of the RO membrane) or flow rate through polisher device 306, may be controlled using control device 305a.

In other words, according to some embodiments, the control unit 112 is configured to determine one or more predetermined properties based on a permeating fluid characteristic detected by at least one detector, e.g., temperature sensor 302 or flow sensor 410. Controlling the permeate fluid properties of the permeate in the permeate path 371a to meet permeate criteria (e.g., to meet the operating point criteria of the RO membrane 324 or polisher device 306). It is configured to control the device 305a.

In a fourth example, the goal is to determine the operating temperature of the RO membrane 324 of the water purification device 300, for example, independently of the ambient temperature or the temperature of the inlet water supplied through the inlet port 399 (FIG. 3). It is maintained at a constant temperature. Because the operating characteristics of RO membrane 324, such as throughput and purification characteristics, are typically dependent on the temperature of RO membrane 324, a constant temperature is generally desirable. A constant operating temperature of the RO membrane may be achieved by maintaining a constant temperature of the water passing through the RO membrane 324. The temperature of the water passing through the RO membrane 324 (T_RO) is (at least essentially) the same as the temperature of the purified water in the permeate path 371a immediately downstream of the RO device 301, i.e. upstream of the heater 302. do. This temperature is the temperature of the inlet water supplied to the inlet port 399 (FIG. 3), the proportion of heated water recycled within the recirculation path 375, and the temperature of the recirculated water, i.e. the temperature of the purified water after the heater (T2) It depends on the same number of factors.

The relationship between the temperature of the purified water before the heater 302 (T_RO) and the temperature of the purified water after the heater 302 (T2) may be calculated using thermodynamics and the formula:

P = Q×cp×ΔΤ →T_R0 = T2-P/(Q×cp) (Equation 1)

where P is the power of heater 302 in Watts, Q is the flow rate through heater 302 [l/s] (equal to the flow rate through RO membrane 324), and T2 is the flow rate through heater 302. is the temperature of the purified water downstream, and T_RO is the temperature upstream of the heater 302 (i.e., the temperature of the water flowing through the RO membrane 324). Therefore, ΔΤ is the temperature difference between the water upstream of the heater 302 and the water downstream of the heater 302, that is, ΔΤ = T2 - T_RO. Moreover, cp is the heat capacity of water. Heat capacity or thermal capacity is a measurable physical quantity equal to the ratio of heat added to (or removed from) an object to its final temperature change. The heat capacity of water is 4.19 kJ/K. For example, if the flow rate (Q) through the RO membrane 324 is 210 ml/min (i.e., 0.0035 1/s), the temperature (T2) of the purified water in the permeate path is 85° C., and the heating power (P) is 200. If W, the final temperature of the RO membrane will be estimated as:

T _R0 = 85 - 200/(0.0035×4190) = 85 - 13.6℃ = 71.4℃ (Equation 2)

The temperature T2 of the purified water in the permeate path 371a may be measured using the temperature sensor 303. Accordingly, the temperature of the RO membrane 324, or rather the temperature of the water flowing through the RO membrane 324, is the permeate since the power of the heater 302 and the flow rate Q through the RO membrane 324 are known. It may also be estimated from the measured temperature (T2) of the purified water in the pathway.

For example, if a change in the temperature (T2) of the purified water in the permeate path (371a) is detected, but the power of the heater (302) and the flow rate (Q) through the heater remain constant, the RO membrane (324) The temperature (T_RO) of the feed water flowing through changed, for example, due to changes in the inlet water or ambient temperature.

One way to achieve the goal of keeping T_RO constant is to then adjust the power P supplied by the heater (i.e., to control the temperature of the recycled water) or the purified water in the permeate path 371a. The flow rate (Q) through heater 302 is varied in response to measured changes in temperature (T2). The flow rate (Q) of water flowing through heater 302 (and RO membrane 324) may be controlled by varying the pumping frequency of RO pump 450. However, in some embodiments it is desirable to use one single pump frequency for all batches of water.

Another way to achieve the goal of keeping T_R0 constant is to vary the amount of heated water that is recirculated within the recirculation path 375. For example, as more heated water is recycled, the temperature of the water in tank 350 will increase. This will in turn increase the temperature of the feed water fed through the feed inlet 301a and thus also the temperature of the water passing through the RO membrane 324 (T_R0).

From the above, it follows that the temperature of the water passing through the RO membrane 324 (T_R0) may be estimated from the measured temperature (T2) of the purified water in the permeate path 371a, using Equation 1. The temperature (T_R0) of the water passing through the RO membrane 324 may then be kept constant by controlling the control device 305a to adjust the rate of permeate fluid recycled within the recirculation path, based on an estimate. For example, the rate of recycled permeate flow within the recirculation path may be continuously adjusted such that the assumed temperature of the water passing through the RO membrane 324 (T_RO) remains constant.

In other words, according to some embodiments, the control unit 112 may use a control device ( It is configured to control 305a). Typically, the control unit 112 is configured to control the control device 305a to control the temperature T_RO such that predefined temperature criteria are met. Criteria include, for example, that the temperature (T_RO) of the water flowing through the RO membrane 324 is maintained within predefined intervals.

Accordingly, the control device 305a may be controlled to maintain the temperature of the water after the RO membrane 324 at a predetermined temperature or within a predetermined temperature interval.

The third and fourth examples may be used in combination with the above embodiments and corresponding product count criteria intended to control product fluid properties of product water within product water path 371c. Next, the different criteria related to pressure, flow and temperature must then be combined (e.g. prioritized and weighted) for optimal control.

In an alternative embodiment, these (third and fourth) embodiments are independent of the previously described embodiment. Next, the control unit 112 then controls the control device 305a (at least simultaneously) to control the product fluid properties of the product water in the product water path 371c to meet one or more predetermined product water criteria. may not be configured, but instead simply uses the control device 305a to control the temperature of the water flowing through the RO membrane 324, for example, based on the temperature detected by the temperature sensor 303. It may also be configured to control.

According to some embodiments, the control unit is configured to activate an alarm function in response to a change in at least one product fluid characteristic detected by at least one detector, such as pressure sensor 308 and/or flow sensor 309. It is composed. For example, to minimize the risk of exceeding a predetermined upper pressure level, the control unit 112 may be configured to trigger an alarm when the pressure measured by the pressure sensor exceeds the predetermined upper pressure level.

An alarm may alternatively be triggered in response to a significant or sudden decrease in pressure or the like, which would serve as an indication of a malfunction. For example, breakthrough of a filter, such as a sterilization grade filter, may cause a pressure drop, thereby causing a pressure decrease and an increase in the flow rate of product water in product water path 371c. Because these events do not coincide, control unit 112 may issue an alert in this situation.

In another example, a leak outside the system between the water purification device 300 and the sterilization grade filters 70a, 70b will also cause a drop in the pressure of the product water in the product water path 371c. A leak would also be a serious error that should trigger an alarm.

In other words, according to some embodiments, control unit 112 is configured to activate the alarm function in response to a change in pressure measured by pressure sensor 308 and/or a change in flow rate measured by flow sensor 309 .

FIG. 4B illustrates the functionality of the control unit 112 of the water purification device 300 according to one example implementation. In this example, the control unit comprises a cascade control device comprising a flow controller 112a and a pressure controller 112b. In a cascade control device, there are two (or more) controllers where the output of one controller drives the set point of the other controller.

In this example, flow controller 112a drives the set point of pressure controller 112b to obtain a predetermined flow rate of product water in product water path 371c. In other words _, the flow rate controller 112a controls the pressure controller ( First control data (d ₁ ) is generated in 112b).

Pressure controller 112b then drives control device 305a to match the flow rate with the set point requested by flow controller 112a, as long as the pressure does not exceed a preset pressure level, for example 300 kPa. In other words, the pressure controller 112b generates the second control data d ₂ based on the first control data d ₁ and the pressure of the product water in the product water path 301c measured by the pressure sensor 308. Occurs. Pressure controller 112b then controls control device 305a using second control data d ₂ .

The controller that drives the set point (flow controller 112a in the above example) is referred to as the primary, external, or master controller. The controller that receives the setpoint (pressure controller 112b in the example) is called a secondary, internal, or slave controller. The control loop frequency of the inner loop may typically be higher than that of the outer loop. For example, the control loop frequency of pressure controller 112b is 10 Hz.

A corresponding method for controlling at least one fluid property in a water purification device 300 that produces purified water will now be described with reference to the flowchart of FIG. 5 and exemplary embodiments in other figures.

The method is typically performed in the control unit 112 of the water purification device 300. The method may be implemented as program code and stored within memory 1123 of control unit 112. Accordingly, the steps of the method may be defined within a computer program that includes instructions that cause the computer to perform the method when the program is executed by a computer, such as control unit 112. Accordingly, the method steps may also be defined within a computer-readable medium, such as a removable memory such as a USB memory stick. The computer-readable medium then includes instructions that, when executed by the computer, cause the computer to perform the method.

In a typical scenario, the method is carried out when the purification device is in the 'running' state and the purification device is supplying product water, for example to a dialysis machine. However, it should be understood that the proposed method may also be performed in the 'connected' or 'idle' state when the product water is not delivered, but is instead recycled within the additional recycling path 381 as illustrated in Figure 6. do.

The method includes detecting at least one fluid characteristic of purified water in purified water path 371 (S1).

According to some embodiments, the detecting step S1 includes detecting at least one product fluid characteristic of the product water in the product water path 371c of the purified water path 371. As described above (Figure 4a), product water path 371c is arranged downstream of recirculation path 375. This step implies that product fluid properties such as pressure and flow rate of product water within the product water path are measured. Typically, the corresponding sensors 308, 309 generate sensor data that is provided to a control unit 112 that performs the method.

The method further includes a step S2 of adjusting the flow rate of water in the recirculation path 375 to meet one or more predetermined criteria of purified water in the purified water path 371 based on at least one detected fluid characteristic.

According to some embodiments, adjusting step S2 may be performed to adjust the product count in recirculation path 375 to meet one or more predetermined product count criteria based on at least one detected product fluid characteristic. It includes the step of controlling the flow rate of water within. In other words, the flow rate of water in recirculation path 375 is adjusted to control specific product fluid properties.

Alternatively, adjusting step S2 may adjust the amount of water in the recirculation path 375 to meet one or more predetermined permeate criteria of the permeate water in the permeate path 371a, based on the at least one detected product fluid characteristic. It includes adjusting the flow rate. An example of a permeate criterion is that the permeate water has a certain pressure or temperature.

For example, the flow rate of water in the recirculation path 375 is adjusted such that the flow rate of product water in the product water path 371c is constant or within a predetermined interval. In other words, according to some embodiments, the at least one product fluid characteristic includes the flow rate of product water in product water path 371c, and then the predetermined product water criterion determines the flow rate of product water in product water path 371c. Includes corresponding to a predetermined flow rate.

In another example, the flow rate of water in recirculation path 375 is adjusted so that the pressure of product water in product water path 371c does not exceed a threshold. In other words, according to some embodiments, the at least one product fluid characteristic includes the pressure of product water within product water path 371c. Next, the predetermined product water criteria include maintaining the pressure of the product water within the product water path 371c below a predetermined upper pressure level.

The detection step (S1) and the adjustment step (S2) are usually carried out sequentially in state 'Run'. Accordingly, any change detected by at least one detector, for example pressure sensor 308 and flow sensor 309, may trigger adjustment step S2. In other words, the method includes continuously performing the detection step (S1) and the adjustment step (S2) while the water purification device 300 produces purified water. The predetermined upper pressure level may be achieved by, for example, at least one filter arranged to filter product water flowing through product water path 371c or any filter arranged within or within a predetermined distance from product water path 371c. Corresponds to the pressure tolerance levels of other components.

According to some embodiments, the method includes activating an alert function in response to a change in at least one product fluid property (S3). In other words, if the detection step indicates a particular change, for example a sudden increase or decrease in pressure, this may be considered an indication of a potential error, as illustrated above with respect to Figure 4A.

In these situations, an alarm function may be triggered to alert the user to a potential error. An alert may be a sound, flashing light, or text message sent or displayed to the user.

In some situations, it may be desirable to generate product water with a specific temperature. The temperature is requested, for example, by a dialysis machine from which the water purification device 300 is requested to deliver purified water. The temperature of the product water may then be controlled accordingly. Accordingly, according to some embodiments, the method includes controlling the temperature of product water flowing within product water path 371c (S4). This may be done by heating by heater 302. The temperature may be set to virtually any temperature, but the range may be limited to 20 to 35°C.

If the flow rate of product water is continuously detected, it is also possible to calculate how much water has passed through the product water path 371c, since the quantity corresponds to the integral of the flow rate. According to some embodiments, the control step includes estimating the amount of purified water produced during the production time based on the duration of the production time and the corresponding flow rate of purified water detected during the production time (S5). The creation time will typically correspond to the time from when the creation starts until it ends, or if the generation is in progress, i.e. the generation has not ended, to the current time.

In the second scenario, i.e. when production is in progress, a predetermined action such as an alarm or notification may be triggered when the desired quantity of products has been produced. The desired amount may, for example, be specified by the user and entered through a user interface. In other words, according to some embodiments, the method includes triggering a predetermined action (S6) when the quantity reaches a certain production volume. The action may be to stop production, notify an attached dialysis machine, or trigger an alarm.

According to some embodiments, the controlling step includes controlling the fluid properties of the purified water through the product water port 128 to obtain a predetermined flow rate for a predetermined time to produce a predetermined amount of water. The predetermined amount is for example between 0.5 and 400 liters. The predetermined amount may correspond, for example, to the volume required for one dialysis treatment or multiple treatments.

As mentioned above, it may also be desirable to keep the operating temperature of the RO membrane 324 fairly constant. Accordingly, according to some embodiments, the method includes measuring the temperature of water in the purified water path 371 downstream of a heater 302 arranged in the purified water path. Next, an adjustment step S2 is performed, based on the temperature detected by the temperature sensor 303, in the recirculation path such that the temperature T_R0 of the water flowing through the RO membrane 324 meets a predetermined temperature criterion. It includes adjusting the flow rate of water. As described above, the adjusting step may in some embodiments be performed in this manner independently or in combination with other embodiments described herein.

6 illustrates an example implementation of a water purification device 300 in greater detail according to some embodiments. In other embodiments, water purification device 300 may include fewer or more components or modules.

The water purification device 300 of FIG. 6 receives water from a water source 398 (FIG. 3), such as potable water or a continuous source of potable water from the patient's home. In various embodiments, water purification device 300 may be installed in a room with access to water source 398 to provide WFPD to circulator 20 as described herein. The water is optionally filtered using a particle pre-filter 334 to remove dirt and sediment before being delivered to the water purification device 300. Water enters the water purification device 300 through the water inlet port 333. As described above, the water purification device 300 includes a pre-treatment module 160, an RO module 170, and a post-treatment module 180. The pretreatment module 160 includes a particle filter and an activated carbon filter, i.e., an activated carbon bed, to further remove contaminants and impurities. The particle filter and activated carbon filter are embodied in a filter package 331. The filter package 331 is a disposable package. Pretreatment module 160 includes an inlet valve 332 and a constant flow device 330 upstream of filter package 331. Inlet valve 332 controls feed water inflow under the control of control unit 112. Constant flow device 330 provides constant flow to tank 350 such that water pressure exceeds a minimum pressure on inlet valve 332.

Moreover, the pretreatment module 160 includes a sampling valve 329 with a sampling port outlet 329a, a tank valve 328, a pretreatment conductivity sensor 327, and a feed water temperature sensor 326 downstream of the filter package 331. Includes. Sampling port outlet 329a allows a sample to be taken from the feed water, for example, to test chlorine levels. Tank valve 328 controls the flow of filtered feed water to tank 350. Pretreatment conductivity sensor 327 monitors the conductivity of the filtered feed water, and feed water temperature sensor 326 monitors the temperature of the filtered feed water. The temperature of the filtered feed water is required, for example, to calibrate the conductivity measurements of the filtered feed water. The components described are included in the feed water path 390. Feed water path 390 is connected to water inlet port 333 and terminates into tank 350. The inlet valve 332 and the tank valve 328 are configured to be controlled by the control unit 112 of the water purification device 300. Water softening in pretreatment module 160 may alternatively or additionally be accomplished using lime softening, ion exchange resins, or anti-scalants such as polyphosphates, as known in the art. there is. It should be understood that filter package 331 is not required in some embodiments and may not be present.

As described above, RO module 170 includes tank 350, RO pump 450, and RO device 301. RO device 301 has already been described in detail with reference to Figure 4A, and reference is made to that description for further explanation. Filtered (or unfiltered) feedwater enters tank 350, for example from the upper portion of tank 350. Feedwater accumulates in tank 350 and is pumped by RO pump 450 to feed inlet 301a (see FIGS. 5-7) of RO device 301.

Empty, low level and high level switches 350a, 350b, 350c are provided in the tank 350 to detect its water level, while a computer program running on the control unit 112 of the water purification device 300 controls the inlet valve 332. ) and is configured to control the opening and closing of the tank valve 328, which is opened during filling of the tank 350 and the water level in the tank 350 is controlled by the high level switch 350c connected to the control unit 112. Closed when activated. When the water level drops below low level switch 350b in tank 350, intake valve 332 opens again, thus tripping the low level switch connected to control unit 112. If the water level in tank 350 rises too high, excess water drains through tank vent line 325 and tank vent 335 (overflow connection), for example into tray 420 or drain 339. do. The tank vent 335 is accessible from the outside of the water purification device 300. The tank vent 335 may be closed, for example, during transportation of the water purification device 300, preventing any water in the tank 350 from flowing into the tray 420 and preventing water from flowing out of the water purification device 300. It will leak out.

The control unit 112 is configured to cause the RO pump 450 to stop pumping when the empty level switch 350a in the tank 350 detects air or a critically low water level. RO pump 450 is configured to provide the water flow and pressure necessary for the reverse osmosis process occurring in RO device 301. For example, as described above with reference to Figure 4A, RO device 301 filters water and provides purified water at its permeate outlet 301b. Reject water leaving RO device 301 at reject outlet 301c may be fed back into RO pump 450 or alternatively pumped to drain 339 to conserve water consumption.

Purified water leaving RO device 301 is conveyed within purification path 371 within purification device 300 before being output through product water port 128. The purified water path 371 includes a permeate water path 371a (as in Figure 4A), a polisher water path 371b, and a product water path 371c. Polisher device 306 may be bypassed via bypass path 371d. Bypass path 371d is connected to the water path upstream of the polisher device 306, here the EDI device, and to the water path downstream of the EDI device. Purified water leaving RO device 301 passes through flow sensor 410, heater 302, and permeate temperature sensor 303 included in permeate path 371a. Flow sensor 410 monitors the flow of purified water leaving RO device 301. Heater 302 heats the purified water leaving the RO device 301 under the control of control unit 112. Permeate temperature sensor 303 monitors the temperature of purified water leaving the RO device 301 immediately downstream of heater 302. An additional conductivity sensor 304 monitors the conductivity of the purified water leaving the RO device 301.

Downstream of heater 302, permeate temperature sensor 303, and conductivity sensor 304, purified water enters post-treatment module 180 via polisher water path 371b. Post-processing module 180 includes a polisher device 306. The three-way valve 305c is configured to be controlled by the control unit 112 to selectively direct purified water flow into the polisher device 306 or into the bypass path 371d to bypass the polisher device 306. are arranged. The polisher device 306 is configured to generate product counts. The product channel valve 307 regulates the flow rate of product water in the product water path 371c from the polisher device 306. The concentrate water path 377c is arranged to pass fluid from the polisher device 306 back to the tank 350.

Product water is passed through the product water port 128 and further into the water lines 64 (64a, 64b) connected thereto of the disposable set 40 for transport to the site. The disposable set 40 includes two sterilizing filters 70a and 70b. The sterilizing filters 70a and 70b filter the product water leaving the product water port outlet 128 into sterilized product water suitable for injection. According to some alternative embodiments, these filters are omitted or the number of filters is less than or greater than two.

Drain port 118 forms a first drain path 384 to drain 339 . Drain line 56 of disposable set 40 is connected to drain port 118 to pass water, such as used PD fluid, from drain port 118 to drain 339. Here, the first drainage path 384 specifies a portion of the circulator drainage path existing inside the water purification device 300. The first drain path 384 includes a conductivity sensor 336, a drain path temperature sensor 315, and a drain line valve 341. Conductivity sensor 336 is configured to measure the conductivity of water in the drainage path. The temperature sensor 315 is arranged to measure the temperature of the water in the first drain path 384. The drain line valve 341 is arranged to regulate the flow in the first drain path 384 through the conductivity sensor 336, under the control of the control unit 112. The first drain path 384 further includes a bypass path 384a arranged to bypass the conductivity sensor 336, the drain path temperature sensor 315 and the drain line valve 341. Bypass path 384a includes valve 340 . Valve 340 is arranged to regulate flow through bypass path 384a.

As in Figure 4a, the control device 305a controls a recirculation path 375 arranged from a point downstream of the heater 302, the permeate temperature sensor 303 and the additional conductivity sensor 304 back to the tank 350. It is configured to control the flow rate of purified water within. A product water pressure sensor 308 is arranged to monitor the product water pressure in the product water path 301c downstream of the polisher device 306. As in Figure 4A, flow sensor 309 is arranged to monitor the flow rate of product water downstream of polisher device 306. The pressure and flow rate of product water are supplied to the control unit 112. The control unit 112 is configured to control the operation of the control device 305a. More specifically, the control unit is configured to adjust the flow rate of water in the recirculation path 375 based on the pressure and flow rate of the product water to control the flow rate of the product water to a desired flow rate and to control the pressure of the product water to a desired pressure. It is composed. The control device 305a is, for example, a motorized flow control valve configured to finely regulate the flow rate of water in the recirculation path 375 .

The product water valve 305d is arranged to control the resulting product water flow to proceed through the additional recirculation path 381 to the product water port 128 or back to the tank 350, under the control of the control unit 112. . An emptying valve 396 is arranged to control the flow rate of water in the additional recirculation path 381. An additional recirculation path 381 is fluidly connected to the product water path 371c via an air trap chamber 319. A product water conductivity sensor 312 is arranged to monitor the conductivity of the product water upstream of the air trap chamber 319. Product water temperature sensor 313 is configured to monitor the temperature of product water upstream of the air trap chamber 319.

In operation, a portion of the rejected water leaving the RO device 301 via fluid path 385a passes through an auxiliary constant flow device 318, which is a three-way valve under the control of control unit 112. 305b) (e.g., a three-way solenoid valve) to provide steady flow of rejected water. The remaining portion of the rejected water returns to the RO pump 450 through valve 320 (e.g., a manual needle valve) in first rejection path 385b. The three-way valve 305b selectively diverts the rejected water through the second drain path 388 to the drain 339 or back to the tank 350 or through the second rejection path 389 back to the tank 350. It is composed of: Bypass path 385f is arranged to bypass auxiliary constant flow device 318. The flow control device 321 is arranged to control the flow in the bypass path 385f by control of the control device 112.

When processing is complete, the water purification device 300 sets itself in a ready-to-disconnect state of the disposable line set 40 (e.g., in response to a message received by the circulator 20) and purifies the product from the outside. The cover (not shown) covering the port 128 and the drain port 118 is closed and the product water port 128 and the drain port 118 are connected by the path 401a, so that the heated fluid Product can flow from the water port 128 into the drain port 118 and further through the first drain path 384 to the drain 339.

All meters and sensors described in connection with the water purification device 300 of FIG. 6 are in some embodiments configured to transmit their corresponding signals to the control unit 112 .

To protect the components of the water purification device 300 as much as possible, for increased reliability, and to prevent bacterial growth, hardware and programs for cleaning are provided by the water purification device 300.

The water purification device 300 also includes a container 392 containing a microbial growth inhibitor. Microbial growth inhibitors are used to prepare cleaning solutions, such as citric acid, and in some embodiments are introduced into the water path. As shown, vessel 392 is in fluid communication with inlet 392a of water purification device 300. 6, line 382 connects vessel 392 to the water path of water purification device 300. Alternatively, vessel 392 may be connected via a line (not shown) leading directly to disposable cassette 42, which operates as circulator 20, or connected to water line 64 or drain line 56. It may also be connected to .

The agent that inhibits microbial growth within container 392 may be a suitable physiologically safe acid, such as citric acid, citrate, lactic acid, acetic acid, or hydrochloric acid (or a combination thereof). In one embodiment, container 392 contains citric acid, citrate, or derivatives thereof. Container 392 may also include additives provided with the acid (e.g., citric acid). Chemical inlet 392a is located at the front of water purification device 300, for example. A presence sensor (not shown, e.g., an optical sensor) is arranged to detect when vessel 392 is connected to chemical inlet 392a. A three-way valve 317 at the chemical inlet 392a is arranged to open towards the tank 350 and a second pump, which is the chemical suction pump 316, under the control of the control unit 112. Chemical suction pump 316 is arranged to supply disinfection solution into tank 350. The optical sensor is arranged to detect whether the source of cleaning or disinfecting solution is connected or disconnected. When vessel 392 is removed and/or not detected by the optical sensor, chemical suction pump 316 is stopped or deactivated and three-way valve 317 is closed towards chemical inlet 392a. The three-way valve 317 may also be used, under the control of control unit 112, to recirculate water and disinfectant to and from tank 350 during phases of chemical disinfection, cleaning, and/or rinsing. . The chemical suction pump 316 and valve 310 are arranged in a path 379 that fluidly connects the three-way valve 317 and the product water path 371c. Valve 310 is arranged to control flow within passage 379.

In a more detailed disinfection phase example, when chemical disinfection is initiated, the level in tank 350 is adjusted to the level just above low level switch 350b. Control unit 112 causes RO pump 450 to start and operate until empty level switch 350a indicates the presence of air. RO pump 450 is then stopped and inlet valve 332 is opened. Inlet valve 332 remains open until empty level switch 350a indicates water. Chemical suction pump 316 is then operated until a preset amount of chemical solution is inserted into tank 350. When the level in tank 350 reaches a predetermined level, three-way valve 317 opens to drain 339. RO pump 450 may operate in two directions to circulate the water in the flow path and create turbulence and increase disinfection time and contact during the chemical intake phase. At the end of the suction phase, the reject bypass valve 321 opens and the three-way valve 305b opens the second drain path 388 to the drain 339 and lowers the water level in the tank 350 to the low level switch 350b. It operates to drain water to its lower level.

The described pre-treatment module 160, RO module 170 and post-treatment module 180 exclude the filter package 331, for example hinged, arranged removably outside the single purification cabinet 110a. Then, it is surrounded inside the single purification cabinet 110a. Filter package 331 may then be replaced when consumed. In alternative embodiments, modules may be arranged as individual units. As described above, purified water is delivered from the water purification device 300 through the water line 64 to the disposable set 40. Referring to Figure 1, water line 64 supplies purified water to water port 282 of cassette 42 of disposable set 40. Water line 64 is, in one embodiment, a flexible tube having a first end connected to product water port 128 of water purification device 300 and a second end connected to water port 282 of circulator 20. Water line 64 may be at least 2 meters long and in one embodiment may be longer than 4 meters. The water line 64 allows the water purification device 300 to be installed in a room with an available water source, while the circulator 20 is in another room where the patient resides, for example sleeping. The water line 64 may therefore be as long as necessary to connect the water purification device 300 to the circulator 20 .

Figure 6 also shows that disposable set 40 includes a drain line 56 arrangement arranged to conduct water, such as used dialysis fluid, to a drain 339 of water purification device 300. Drain line 56 includes, for example, a first end connected to cassette 42 of circulator 20 and a drain line connector 58 (FIG. 1) connected to drain port 118 of water purification device 300. It is a tube having a second end. Drain line 56 may alternatively be a flexible tube that may be greater than 2 meters in length, and in some embodiments may be longer than 4 meters. Drain line 56 may be as long as necessary to connect between water purification device 300 and circulator 20. In the depicted embodiment the water line 64 and drain line 56 run parallel using double lumen tubing. It is also possible for the purification device 300 and the circulator 20 to be located close together, so that the same two line water path comprising the water line 64 and the drain line 56 may be less than 0.5 meters, for example. do. Furthermore, although a dual lumen water line 64 and drain line 56 are shown, it is possible for the water line 64 and drain line 56 to be separate.

A water tray 420 is located below the water purification device 300. A liquid sensor 370 is arranged at the bottom of the water tray 420 to detect any leakage from the water purification device 300.

The present disclosure is not limited to the preferred embodiments described above. Various alternatives, modifications and equivalents may be used. Accordingly, the above examples should not be taken as limiting the scope of the disclosure as defined by the appended claims.

Claims (23)

As a water purification device 300,
A reverse osmosis device (301) configured to produce purified water, the reverse osmosis device (301) comprising a feed inlet (301a) positioned to receive feed water and a purified water outlet (301b). 301);
a reverse osmosis pump (450) configured to pump feed water to the feed inlet (301a);
a recirculation path (375) configured to recirculate a portion of the purified water from a first point downstream of the reverse osmosis device (301) to a second point upstream of the reverse osmosis device (301);
A purified water path 371 configured to transport purified water from the purified water outlet 301b to a destination, wherein the purified water path 371 includes i) a permeated water path 371a located upstream of the recirculation path 375 and the recirculation It includes a product water path 371c located downstream of the path 375 and transporting the product water to the destination, wherein the permeate water path 371a includes a recirculation path 375 and a product water path 371c at the first point. ), a purified water path (371) separated by;
A flow sensor 410 configured to detect the flow rate of purified water in the permeate path 371a;
A control unit 112 configured to control the reverse osmosis pump 450 at a specific pump speed corresponding to a specific flow rate of purified water passing through the permeate path 371a;
A heater (302), wherein the heater (302) is located downstream of the reverse osmosis device (301) to heat purified water flowing in the purified water path (371); and
A temperature sensor 303 positioned to measure the temperature of the purified water downstream of the heater 302, wherein the control unit 112 is configured to maintain the temperature of the reverse osmosis membrane 324 within a predefined interval. A temperature sensor (303), wherein the temperature sensor (303) is configured to control the temperature of the feed water flowing through the reverse osmosis membrane (324) of the reverse osmosis device (301) based on the temperature sensed by the temperature sensor (303).
A water purification device comprising a. The method of claim 1, wherein the flow rate sensor (410) is a first flow rate sensor, and the water purification device (300) includes a second flow rate sensor (309) configured to sense the flow rate of product water in the product water path (371c). A water purification device. 2. The method of claim 1, comprising at least one pressure sensor (308) positioned and arranged to sense the pressure of the purified water in the purified water path (371), wherein the control unit (112) is configured to: A water purification device, wherein the water purification device is configured to use the sensed pressure to control, such that it remains below a pressure level or ii) attempts to achieve a predetermined pressure. 2. A water purification device according to claim 1, further comprising a tank (350) configured to receive water from an external water source and provide feed water to the feed inlet (301a) of the reverse osmosis device (301). 5. A water purification device according to claim 4, wherein water from an external water source flows through a filter package (331) before reaching the tank (350). 5. Water purification device according to claim 4, wherein the second point upstream of the reverse osmosis device (301) for the recirculation path (375) is provided in the tank (350). 5. A water purification device according to claim 4, comprising a vent line (325) extending from the top of the tank (350). 8. A water purification device according to any one of claims 1 to 7, further comprising a polisher device (306) located downstream of the reverse osmosis device (301) in the purified water path (371). 9. A water purification device according to claim 8, wherein the permeate water path (371a) is positioned to convey purified water from the purified water outlet (301b) of the reverse osmosis device (301) to the inlet of the polisher device (306). 9. A water purification device according to claim 8, wherein the product water path (371c) is positioned and arranged to convey purified water from the outlet of the polisher device (306) to its destination. 3. A water purification device according to claim 1 or 2, comprising a flow control device (305a) located along the recirculation path (375). 3. A water purification device according to claim 1 or 2, wherein the destination includes a product water port (128). 3. A detector (308, 309, 313) according to claim 1 or 2, configured to sense fluid properties within the product water path (371c) and a flow control device (305a) positioned along the recirculation path (375). and wherein the control unit (112) is configured to control the flow control device (305a) based on the fluid properties detected by the detectors (308, 309). 14. The water purification device of claim 13, wherein the fluid properties include fluid pressure, fluid flow rate, or fluid temperature. A peritoneal dialysis system, comprising:
As a water purification device,
A reverse osmosis device (301) configured to produce purified water, the reverse osmosis device (301) comprising a feed inlet (301a) and a purified water outlet (301b) positioned to receive feed water;
a reverse osmosis pump (450) configured to pump feed water into the feed inlet (301a);
a recirculation path (375) configured to recycle a portion of the purified water from a first point downstream of the reverse osmosis device (301) to a second point upstream of the reverse osmosis device (301);
A purified water path 371 configured to transport purified water from the purified water outlet 301b to a destination, wherein the purified water path 371 includes i) a permeated water path 371a located upstream of the recirculation path 375, ii) and a product water path 371c positioned downstream of the recirculation path 375 to transport the product water to its destination, wherein the permeate water path 371a includes a recirculation path 375 and a product water path (371a) at the first point. a purified water path 371 that is separated into 371c);
A flow sensor 410 configured to detect the flow rate of purified water in the permeate path 371a;
A control unit 112 configured to control the reverse osmosis pump 450 at a specific pump speed corresponding to a specific flow rate of purified water passing through the permeate path 371a;
a heater (302), wherein the heater (302) is located downstream of the reverse osmosis device (301) to heat purified water flowing in the purified water path (371); and
A temperature sensor 303 positioned to measure the temperature of the purified water downstream of the heater 302, wherein the control unit 112 adjusts the temperature of the reverse osmosis membrane 324 to maintain the temperature within a predetermined interval. A temperature sensor (303), wherein the temperature sensor (303) is configured to control the temperature of the feed water flowing through the reverse osmosis membrane (324) of the reverse osmosis device (301) based on the temperature sensed by the sensor (303).
A water purification device 300 including; and
A peritoneal dialysis circulator positioned and arranged to utilize peritoneal dialysis fluid during peritoneal dialysis (PD) treatment, wherein the peritoneal dialysis fluid is mixed using product water from the water purification device (300).
A peritoneal dialysis system comprising: 16. The peritoneal dialysis system of claim 15, wherein the destination comprises a product water port (128). A method for controlling at least one fluid property in a water purification device, the water purification device (300) comprising a reverse osmosis device (301) configured to produce purified water and a portion of the purified water from a first point downstream of the reverse osmosis device (301). a recirculation path (375) arranged to recycle to a second point upstream of the reverse osmosis device (301), the method comprising:
Arranging the purified water path 371 to include i) a permeate path 371a located upstream of the recirculation path 375 and ii) a product water path 371c located downstream of the recirculation path 375. ;
separating the permeate path (371a) into a recirculation path (375) and a product water path (371c) at a first point;
Controlling the reverse osmosis pump 450 to a specific pump speed corresponding to a specific flow rate of purified water passing through the permeate path 371a;
monitoring a temperature sensor 303 positioned to sense the temperature of the purified water; and
Controlling the temperature of water flowing through the reverse osmosis membrane 324 of the reverse osmosis device 301 based on the temperature sensed by the temperature sensor 303 to maintain the temperature of the reverse osmosis membrane 324 within a predetermined interval. step
How to include . 18. The method of claim 17, further comprising an estimating step of estimating the amount of product water produced during the production period based on the duration of the production period and the corresponding flow rate of purified water detected during the production period. 19. The method of claim 18, further comprising triggering a predetermined action when the quantity reaches a predefined production volume. 20. The method according to claim 18 or 19, comprising: monitoring at least one pressure sensor (308) positioned and arranged to sense the pressure of the purified water in the purified water path (371), and determining whether the pressure of the purified water is i) a predetermined upper pressure; A method comprising using the sensed pressure to control, such that it remains below a level or ii) attempts to achieve a predetermined pressure.

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